Acetylsalicylsyra Mylan 100 mg Enterotablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

08-05-2019

Produktens egenskaper Produktens egenskaper (SPC)

17-05-2019

Aktiva substanser:
acetylsalicylsyra
Tillgänglig från:
Mylan AB
ATC-kod:
B01AC06
INN (International namn):
acetylsalicylic acid
Dos:
100 mg
Läkemedelsform:
Enterotablett
Sammansättning:
laktosmonohydrat Hjälpämne; acetylsalicylsyra 100 mg Aktiv substans
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Blister, 30 tabletter
Bemyndigande status:
Godkänd
Godkännandenummer:
57789
Tillstånd datum:
2019-05-17

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

04-06-2021

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

05-12-2019

Läs hela dokumentet

Package leaflet: Information for the patient

Acetylsalicylsyra Mylan 100 mg gastro-resistant tablets

acetylsalicylic acid

[For medicines available only on prescription:]

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

[For medicines available without a prescription:]

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have

told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

What <Invented name> is and what it is used for

What you need to know before you take <Invented name>

How to take <Invented name>

Possible side effects

How to store <Invented name>

Contents of the pack and other information

1.

What <Invented name> is and what it is used for

<Invented name> contains acetylsalicylic acid, which in low doses belongs to a group of medicines

called anti-platelet agents. Platelets are tiny cells in the blood that cause the blood to clot and are

involved in thrombosis. When a blood clot occurs in an artery it stops the blood flowing and cuts off

the oxygen supply. When this happens in the heart it can cause a heart attack or angina; in the brain it

can cause a stroke.

<Invented name> is taken to reduce the risk of blood clots forming and thereby prevent further:

heart attacks.

strokes.

cardiovascular problems in patients who suffer from stable or unstable angina (a type of chest

pain).

<Invented name> is also used to prevent the formation of blood clots after certain types of heart

surgery in order to widen or to unblock the blood vessels.

This medicine is not recommended for emergencies. It can only be used as a preventive treatment.

2.

What you need to know before you take <Invented name>

Do not take <Invented name>:

if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed

in section 6).

if you are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs).

NSAIDs are often used for arthritis or rheumatism and pain.

if you have had an asthma attack or swelling of some parts of the body e.g. face, lips, throat or

tongue (angioedema) after taking salicylates or NSAIDs.

if you currently have or have ever had an ulcer in your stomach or small intestine or any other

type of bleeding like a stroke.

if you have ever had the problem of your blood not clotting properly.

if you have severe liver or kidney problems.

if you have severe heart problems which can cause shortness of breath and ankle swelling.

if you are in your last 3 months of pregnancy; you must not use higher doses than 100 mg per

day (see section “Pregnancy and breast-feeding”).

if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in

doses higher than 15 mg per week.

Warnings and precautions

Talk to your doctor or pharmacist before taking <Invented name>:

if you have kidney, liver or heart problems.

if you have or have ever had stomach or small intestine ulcers that may cause bleeding. This

type of ulcers are open sores that develop on the lining of the stomach and small intestine.

if your taking anticoagulant medicines (used to prevent blood clots).

if you have uncontrolled high blood pressure.

if you are asthmatic, have hay fever, swelling of the mucosa in the nose (nasal polyps) or other

chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack.

If you are elderly. Older people are particularly susceptible to the side effects of NSAIDs,

including acetylsalicylic acid.

if you have ever had gout.

if you have heavy menstrual periods.

If you are taking medicines that can change the process which causes bleeding to stop, meaning

to keep blood within a damaged blood vessel (haemostasis).

If you are taking medicines that can increase the risk of developing ulcers such as oral

corticosteroids (often used to relief inflammation), selective serotonin-reuptake inhibitors

(typically used as antidepressants) and deferasirox (used to remove the excess iron from the

body).

if you suffer from a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

You must immediately seek medical advice, if your symptoms get worse or if you experience severe

or unexpected side effects e.g. unusual bleeding symptoms, serious skin reactions or any other sign of

serious allergy (see section “Possible side effects”).

Tell your doctor if you are planning to have an operation (even a minor one, such as tooth extraction)

since acetylsalicylic acid is blood-thinning there may be an increased risk of bleeding.

You should take care not to become dehydrated (you may feel thirsty with a dry mouth) since the use

of acetylsalicylic acid at the same time may result in deterioration of kidney function.

This medicinal product is not suitable as an anti-inflammatory, pain killer or fever reducer.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid may cause Reye’s syndrome when given to children. Reye’s syndrome is a very

rare disease which affects the brain and liver and can be live threatening. For this reason, <Product

name> should not be given to children aged under 16 years, unless on the advice of a doctor.

Other medicines and <Invented name>

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as some

other medicines for:

thinning of the blood/prevention of clots or dissolving (e.g. coumarin, warfarin, heparin,

clopidogrel, alteplase, ticlopidine, cilostazol and dipyridamole).

rejection of organ after transplantation (cyclosporine, tacrolimus).

high blood pressure (e.g. diuretics and ACE-inhibitors).

regulation of the heart beat (digoxin).

manic-depressive illness (lithium).

pain and inflammation (e.g. NSAIDs such as ibuprofen, or steroids).

gout (e.g. probenecid, sulfinpyrazone).

epilepsy (valproate, phenytoin).

glaucoma (acetazolamide).

cancer or rheumatoid arthritis (methotrexate;

in doses lower than 15 mg per week).

diabetes (e.g. sulphonylureas, insulin).

depression (selective serotonin re-uptake inhibitors (SSRIs) such as sertraline or paroxetine).

use as hormone replacement therapy when the adrenal glands or pituitary gland have been

destroyed or removed, or to treat inflammation, including rheumatic diseases and inflammation

of the intestines (corticosteroids).

Metamizole (substance to decrease pain and fever) may reduce the effect of acetylsalicylic acid on

platelet aggregation (blood cells sticking together and forming a blood clot), when taken

concomitantly. Therefore, this combination should be used with caution in patients taking low dose

aspirin for cardioprotection.

<Invented name> with alcohol

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding

time.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by their doctor.

You should not take <Invented name> if you are in the last 3 months of pregnancy, unless you are

advised to do so by your doctor and then the daily dose should not exceed 100 mg (see section “Do

not take <Invented name>”). Regular or high doses of this medicinal product during late pregnancy

can cause serious complications in the mother or baby.

Breast-feeding

Breast-feeding women should not take acetylsalicylic acid unless advised by their doctor.

Driving and using machines

<Invented name> should not affect your ability to drive and use machines.

<Invented name> contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicinal product.

3.

How to take <Invented name>

[For medicines available only on prescription:]

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

[For medicines available without a prescription:]

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have

told you. Check with your doctor or pharmacist if you are not sure.

Adults

Prevention of heart attacks:

The recommended dose is 100 mg once daily.

Prevention of strokes:

The recommended dose is 100 mg once daily.

Prevention of cardiovascular problems in patients who suffer from stable or unstable angina (a type

of chest pain):

The recommended dose is 100 mg once daily.

Prevention formation of blood clots after certain types of heart surgery:

The recommended dose is 100 mg once daily.

This medicine should not be used at higher doses unless advised by a doctor, and then the dose should

not exceed 100 mg a day.

Elderly

As for adults. <Invented name> should be used with caution in elderly patients who are more prone to

adverse events. Treatment should be reviewed at regular intervals.

Use in children and adolescents

<Invented name> should not be administered to children and adolescents younger than 16 years, unless

prescribed by a doctor (see section “Warnings and precautions”).

Method of administration

For oral use.

Swallow the tablets whole with sufficient fluid (1/2 glass of water). The tablets have a gastro-resistant

coating which prevents irritant effects on the gut, and should therefore not be crushed, broken or chewed.

If you take more <Invented name> than you should

If you (or someone else) accidentally take too many tablets, you should tell your doctor at once or

contact immediately the nearest casualty department. Show any leftover medicines or the empty

packet to the doctor.

Symptoms of overdose may include ringing in ears, hearing problems, headache, dizziness, confusion,

nausea, vomiting and abdominal pain. A large overdose can lead to more rapid breathing than normal

(hyperventilation), fever and excess sweating that may result in dehydration (you may feel restless,

suffer fits (seizures), hallucinations, low blood sugar), coma and shock.

If you forget to take <Invented name>

If you miss a dose, wait until it is time for your next dose, then go on as normal.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking <Invented name>

Talk to your doctor before you stop taking this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking <Invented name> and contact

a doctor immediately:

Rare side effects (may affect up to 1 in 1,000 people)

Severe allergic reactions that can present the following symptoms: swelling of the face, tongue,

larynx, abdomen, or arms and legs, itchy rash, shortness of breath, vomiting, lightheadedness,

and low blood pressure.

Reddening of the skin with blisters or peeling and may be associated with a high fever and joint

pain. This could be erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome.

Brain haemorrhage (acute bleeding inside your skull or brain). The symptoms might include

sudden severe headache and stroke-like symptoms – such as slurred speech and weakness on

one side of the body, feeling or being sick, changes in vision, seizures or loss of consciousness.

Frequency not known (cannot be estimated from the available data)

Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.

Acute renal failure (sudden damage to the kidneys that causes them to not work properly). The

symptoms might include feeling or being sick, dehydration, confusion, high blood pressure,

pain in the tummy, slight backache and a build-up of fluid in the body.

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

Nausea, vomiting, diarrhoea.

Indigestion.

Increased tendency for bleeding.

Uncommon side effects

(may affect up to 1 in 100 people)

Hives.

Runny noses.

Breathing difficulty.

Rare side effects (may affect up to 1 in 1,000 people)

Severe bleeding in the stomach or intestines.

Altered number of blood cells.

Bronchospasm (tightening of the muscles that line the airways (bronchi) in your lungs: your

chest feels tight and it can be hard to catch your breath).

Asthma attack.

Inflammation in the blood vessels.

Bruising with purple spots (cutaneous bleeding).

Erythema nodosum (swollen fat under the skin causing red bumps and patches).

Reye’s syndrome (a very rare disease in children which affects the brain and liver (see section 2

“Children and adolescents”).

Abnormal heavy or prolonged menstrual periods

Frequency not known (cannot be estimated from the available data)

Ringing in your ears (tinnitus) or reduced hearing ability.

Headache.

Vertigo (feels like you or everything around you is spinning).

Ulcers in stomach or small intestine and perforation.

Prolonged bleeding time such as nasal bleeding and bleeding gums.

Impaired kidney function.

Impaired liver function.

increased liver enzymes on blood tests.

High level of uric acid in the blood.

Low levels of sugar

in the blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via [to be completed nationally]. By

reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store <Invented name>

Keep this medicine out of the sight and reach of children.

Do not store above 30 °C.

Do not use this medicine after the expiry date which is stated on the label and carton after “EXP:”.

The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What <Invented name> contains

The active substance is acetylsalicylic acid.

Each tablet contains 100 mg acetylsalicylic acid.

The other ingredients are

lactose monohydrate, microcrystalline celullose, colloidal anhydrous

silica, potato starch, talc, triacetin and methacrylic acid – ethylacrylate copolymer (1:1).

What <Invented name> looks like and contents of the pack

<Invented name> is formed of white coloured, round, biconvex gastro-resistant coated tablets with

approximately 8.1 mm of diameter and 3.5 mm of thickeness.

Each pack contains blisters with 30 tablets.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following

names:

France

Acide acétylsalicylique Mylan 100 mg, comprimé gastro-résistant

Italy

Acido acetilsalicilico Mylan

Portugal

Ácido Acetilsalicílico Mylan

Sweden

Acetylsalicylsyra Mylan

Spain Ácido Acetilsalisílico Mylan Pharmaceuticals 100 mg comprimidos

gastrorresistentes

This leaflet was last revised in

2020-04-20

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